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(Sr) Manufacturing operator USP/DSP

Are you experienced in USP/DSP manufacturing? would you like to be the person that is helping realizing a COVID-19 vaccine? Continue reading, we would like to get in contact!

Job Description
Our client Janssen Vaccines & Prevention B.V. is passionate about the development, production and marketing of vaccines to prevent and combat infectious diseases.he Drug Substance Operations(DSO) department has a GMP manufacturing facility at the Bioscience Park in Leiden
where they proudly produce groundbreaking medicines against diseases that have a global impact, such as vaccines against HIV, RSV, Ebola and of course COVID-19.

The department is working on the manufacturing of cell banks, virus seeds and clinical batches (phase I to III) to supportthe development of new vaccine candidates. Manufacturing activities are performed under strict cGMP regulations and the process is established together with development departments, engineering & maintenance, QC, QA and warehouse. In this role you are primary responsible for acute problem solving of issues that manifest during operations to ensure the continuation of the production processes for cGMP clinical trial material. Analyzing the issues and following up on the solution is your main task. For this, you will need to connect with specialists and partners inside and outside the department.

Responsibilities

  • Ensuring continuation of production operations;

  • Updating documentation to resolve the issues that you found.

  • To improve the operations, small improvements and innovative projects will be a stable part of your daily work package.

  • You will also be tasked in other small and diverse tasks as well as reviewing batch documentation.

Requirements

  • HBO/BSc with > 2 years of proven experience in pharmaceutical/biotechnology;

  • OR MLO-4> 5 years of relevant experience;

  • Expert in cell culture (USP), virus propagation and/or downstream processing (DSP);

  • Experience with change controls, non-conformances and CAPA records;

  • Experience with cGMP and EHSS standards is required;

  • Lean green belt certification is preferred;

  • the right candidate...

  • has a high degree of accuracy, initiative, and independence

  • is flexible and stress-resistant and remains positive when priorities change

  • helps team members by giving advice and sharing feedback on technical and personal level

  • has great social and trainer skills, is able to provide and receive feedback in a constructive way. You make yourself part of discussions and help transform these into positive actions.

  • English and Dutch spoken and written;

Benefits

  • Contract: 1 year through Oxford Global Resources, long term possibilities anticipated but no promises can be made at this stage;

  • Salary: €3000,- till €3400,- gross monthly based on education level of experience;

  • Hours full-time preferred, 32h discussable;

  • Holidays: 25 (+12);

  • Startdate: Asap;

Vacancy number: 15553